Updated: VA puts Gilead's $1,000-a-pill hepatitis C drug on its list of meds

Updated: May 9, 2014, 8:05am PDT

VA puts Gilead's $1,000-a-pill hepatitis C drug on its list of meds

Ron Leuty
Reporter- San Francisco Business Times

Gilead Sciences Inc.'s controversial hepatitis C drug Sovaldi is on the approved list of medicines for the Veterans Affairs hospital system, company officials said, clearing the way for the drug's use by the largest U.S. provider of hepatitis C care.

The VA agreed last month to place Sovaldi on its formulary, clearing doctors' use of the $1,000-a-pill drug to cure patients with the viral infection, Gilead President John Milligan said at the company's annual stockholders meeting in Millbrae.

Chronic hepatitis C is the leading cause of liver cancer and liver transplants but also carries other physical and mental health problems.

The formulary decision by the VA comes as a panel assembled by the system last month recommended that doctors warehouse hepatitis C patients, putting those with advanced liver disease on Sovaldi first.
By triaging patients, health care providers can absorb the patient load — and Sovaldi's cost — over 10 to 15 years, said Gilead President John Milligan. What's more, the strategy allows those lower-risk patients to receive next-generation treatments under development by Gilead and others.

The treatment strategy is similar to that pursued by the VA in the early days of antiretroviral drugs developed by Foster City-based Gilead (NASDAQ: GILD) to treat the AIDS virus, Milligan said. In that case, HIV patients were prioritized by the amount of a particular protein, called CD4, found on the surface of immune cells.

Insurance companies and others that pay for treatments have balked at Sovaldi's price, saying its use by large numbers of hepatitis C patients could break them as well as government programs that pay for the bulk of care.

But patients apparently have voted with their feet since Sovaldi's approval in December by the Food and Drug Administration. Gilead last month said it sold $2.27 billion of Sovaldi in the first quarter, making it the fastest drug launch ever in terms of dollars.

Some 30,000 patients shave tarted treatment with the drug since its launch, Milligan said. That is a higher volume than even Gilead predicted, he said.
It is difficult for the VA to treat hepatitis C patients with interferon because many patients can't tolerate the protein even for the 12 weeks it is used in combination with Sovaldi and ribavirin, Milligan said.

Patients have long complained of the side effects caused by the standard 48 weeks of treatment with interferon and ribavirin to flush the virus from their bodies. Those side effects are so bad that some patients stop treatment.
"Patients gave up. This changed it," Milligan said.

Hepatitis C patients who are healthier could wait until Gilead has developed an all-oral drug, eliminating injections of interferon and ribavirin.

A once-daily treatment that combines Sovaldi and experimental ledipasvir is under consideration by the FDA. That treatment initially is aimed at chronic hepatitis C patients with genotype 1 infection, the strain of the potentially deadly disease that affects roughly three of every four patients.
An FDA decision could come by Oct. 10.

Sovaldi is designed to block a specific enzyme of the virus that causes hepatitis C. Ledipasvir, meanwhile, is what is known as an "NS5A inhibitor," blocking a protein that plays a key role in the replication of the virus.

Source - San Francisco Business Times